BS ISO 11040-5:2012

Comprehensive Standard for Prefilled Syringes

BS ISO 11040-5:2012 is the essential standard for healthcare professionals and manufacturers working with prefilled syringes. This comprehensive document outlines the design, materials, and testing requirements to ensure the safety, quality, and compliance of these critical medical devices.

Ensuring Patient Safety and Product Reliability

Prefilled syringes play a crucial role in modern healthcare, providing accurate dosing, reducing medication errors, and improving patient outcomes. BS ISO 11040-5:2012 sets the benchmark for these products, addressing key considerations such as:

• Design Specifications: Detailed requirements for the syringe barrel, plunger, and other components to maintain structural integrity and functionality.
• Material Selection: Guidelines for choosing biocompatible materials that are compatible with the drug formulation and minimize the risk of contamination.
• Sterilization and Packaging: Protocols for ensuring the sterility of prefilled syringes throughout the supply chain, from manufacturing to patient administration.
• Performance Testing: Comprehensive testing procedures to evaluate critical characteristics, such as gliding force, break-loose force, and extractable/leachable levels.

Compliance and Regulatory Alignment

Adhering to BS ISO 11040-5:2012 helps healthcare organizations and manufacturers demonstrate their commitment to patient safety and regulatory compliance. This standard is aligned with the following key regulations and guidelines:

• ISO Standards: Harmonized with the ISO 11040 series, ensuring global consistency and recognition.
• European Pharmacopoeia: Complies with the relevant monographs and general chapters, meeting the strict quality requirements for medicinal products.
• FDA Guidance: Addresses the key considerations outlined in the FDA's guidance for prefilled syringes, including container closure integrity and leachable/extractable testing.

Comprehensive Guidance for Healthcare Professionals

BS ISO 11040-5:2012 is an invaluable resource for healthcare professionals involved in the selection, procurement, and use of prefilled syringes. By adhering to this standard, organizations can:

• Ensure the safety and efficacy of prefilled syringe products, minimizing the risk of medication errors and adverse events.
• Streamline procurement processes and establish clear quality criteria for evaluating and selecting prefilled syringe suppliers.
• Demonstrate compliance with relevant regulations and guidelines, mitigating legal and reputational risks.
• Stay up-to-date with the latest industry best practices and technological advancements in prefilled syringe design and manufacturing.

Whether you're a healthcare provider, procurement specialist, or quality assurance professional, BS ISO 11040-5:2012 is a must-have resource for ensuring the safe and effective use of prefilled syringes in your organization.